A Randomized, Controlled Study of Diet and Multiple Sclerosis
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Number of new MS T2 lesion formation on brain MRI in those randomized to the low fat study diet with that of subjects randomized to follow their regular diet.
Study Overview
Brief Summary
The purpose of this study is to evaluate if following a specific low fat diet will improve the brain damage as seen by Magnetic Resonance Imaging (MRI) and to decrease the progression of multiple sclerosis (MS) as evidenced by clinical evaluation and symptoms.
Detailed Description
This research project has significance for its potential to develop a new therapeutic approach to MS. Current treatments in MS include disease modifying therapies such as human recombinant interferon beta, glatiramer acetate and natalizumab. However, these are only partially effective, cannot be taken orally, have side-effects and are very expensive. Developing treatment that can be combined with current disease modifying agent remains an important goal for improving the care of people with MS.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of the relapsing-remitting form of MS
- •Age 18-70, inclusive
- •MS duration of less than 15 years
- •May or may not be on disease-modifying therapies for MS, but if on, must be on for more than 6 months of continuous therapy
- •Should not have diabetes
- •Able and willing to follow exercise instructions
- •Able and willing to travel to California for 10-day training program (cost covered by study)
- •Able and willing to travel to Portland, OR for 6 study visits over the 12 month study period (cost covered by study)
Exclusion Criteria
- •No clinically significant MS exacerbation within 30 days of screening visit
- •No systemically administered corticosteroids within 30 days of study entry
- •Patient not pregnant or breastfeeding
- •Not taking fish oil/flax seed for at least 2 months prior to first visit
- •No other significant health programs (e.g. active coronary heart disease, liver disease, pulmonary disease) that might increase risk of patient experiencing adverse events
Arms & Interventions
1. Low fat study diet
The low fat study diet arm will receive low fat diet training and followed for 12 months on the diet.
Intervention: Low fat study diet (Other)
2. Regular diet group
The regular diet arm will be a wait-listed group that will receive no training in diet and will be advised to continue their regular (usual) diet as was prior to entry into the study, for the duration of the study. They will have a similar clinic follow up schedule as the treatment group. The regular diet group will be given identical instructions to exercise regularly similar to the treatment group.
Outcomes
Primary Outcomes
Number of new MS T2 lesion formation on brain MRI in those randomized to the low fat study diet with that of subjects randomized to follow their regular diet.
Time Frame: Baseline. Month 12.
Secondary Outcomes
- To study the effects of the Low Fat Study Diet on serum markers of inflammation(Baseline. Month 6. Month 12.)
- To assess safety and tolerability of the low fat study diet upon 12 months of administration(Baseline. Month 3. Month 6. Month 9. Month 12.)
- To assess effects of the low fat study diet on clinical activity of MS as by relapse rate and disability progression and on fatigue, depression and quality of life.(Baseline. Month 3. Month 6. Month 9. Month 12.)
Investigators
Vijayshree Yadav
Principal Investigator
Oregon Health and Science University